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General Information

Breo Ellipta is a combination of fluticasone furoate, an inhaled corticosteroid (ICS), and vilanterol, a long-acting beta2-adrenergic agonist (LABA).

BreoEllipta is specifically indicated for the long-term, once-daily, maintenance treatment of airflow
obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic
bronchitis and/or emphysema. Breo Ellipta is also indicated to reduce exacerbations of
COPD in patients with a history of exacerbations.

Breo Ellipta is supplied as a powder for inhalation. The recommended dose is 100 mcg/25 mcg administered as 1 inhalation once daily by the orally inhaled route only. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. Breo Ellipta should be taken at the same time every day. Do not use more than 1 time every 24 hours.

Clinical Results

FDA ApprovalThe FDA approval of Breo Ellipta was based on 4 confirmatory trials of 6- and 12-months’ duration, three 12-week active comparator trials, and dose-ranging trials of shorter duration. Dose-Ranging TrialsVilanterol: Dose selection for vilanterol in COPD was supported by a 28-day, randomized, double-blind, placebo-controlled, parallel-group trial evaluating 5 doses of vilanterol (3 to 50 mcg) or placebo dosed in the morning in 602 patients with COPD. Results demonstrated dose-related increases in FEV1 compared with placebo at Day 1 and Day 28 . These results supported the evaluation of vilanterol 25 mcg in the confirmatory COPD trials. Fluticasone furoate: Eight doses of fluticasone furoate ranging from 25 to 800 mcg once daily were evaluated in 3 randomized, double-blind, placebo-controlled, 8-week trials in subjects with asthma. A dose-related increase in trough FEV1 at Week 8 was seen for doses from
25 to 200 mcg with no consistent additional benefit for doses above 200 mcg. To evaluate dosing frequency, a separate trial compared fluticasone furoate 200 mcg once-daily, fluticasone furoate 100 mcg twice-daily, fluticasone propionate 100 mcg twice-daily, and fluticasone propionate 200 mcg twice-daily. The results supported the selection of the once-daily dosing frequency. Based on the dose-ranging trials in asthma and COPD, once-daily doses of fluticasone furoate/vilanterol 50 mcg/25 mcg, 100 mcg/25 mcg, and 200 mcg/25 mcg were evaluated in the confirmatory COPD trials.Confirmatory TrialsFour confirmatory trials in
subjects with COPD were designed to evaluate the efficacy of Breo Ellipta on lung function (Trials 1 and 2) and exacerbations (Trials 3 and 4).Trials 1 and 2: Lung FunctionThese 24-week, randomized, double-blind,
placebo-controlled trials enrolled 2,254 subjects. In Trial 1, subjects were randomized to Breo Ellipta 100 mcg/25 mcg, fluticasone furoate/vilanterol 200 mcg/25 mcg, fluticasone furoate 100 mcg, fluticasone furoate 200 mcg, vilanterol 25 mcg, and placebo. In Trial 2, subjects were randomized to Breo Ellipta 100 mcg/25 mcg, fluticasone furoate/vilanterol 50 mcg/25 mcg, fluticasone furoate 100 mcg, vilanterol 25 mcg, and placebo. All treatments were administered as 1 inhalation once daily. The co-primary efficacy variables in both trials were weighted mean FEV1 (0 to 4 hours)
postdose on Day 168 and change from baseline in trough FEV1 on Day 169 (the mean of the FEV1 values obtained 23 and 24 hours after the final dose on Day 168). Breo Ellipta 100 mcg/25 mcg demonstrated a larger increase in the weighted mean
FEV1 (0 to 4 hours) relative to placebo and fluticasone furoate 100 mcg at Day 168. At Day 169, both Trials 1 and 2 demonstrated significant increases in trough
FEV1 for all strengths of the fluticasone furoate/vilanterol combination compared with placebo.

Side Effects

Adverse events associated with the use of Breo Ellipta may include, but are not limited to, the following:

nasopharyngitis

upper respiratory tract infection

headache

oral candidiasis

Mechanism of Action

Breo Ellipta is a combination of fluticasone furoate, an inhaled corticosteroid (ICS), and vilanterol, a long-acting beta2-adrenergic agonist (LABA).